clinicedc

Here are a set of python modules that extend Django to empower you to build an EDC / eSource system to handle data collection and management for multi-site longitudinal clinical trials.

Refer to the specific open projects listed below for example EDC systems built with these modules. The more recent the trial the better the example.

The codebase continues to evolve over many years of conducting clinical trials for mostly NIH-funded clinical trials through the Harvard T Chan School of Public Health, the Botswana-Harvard AIDS Institute Partnership in Gaborone, Botswana and the London School of Hygiene and Tropical Medicine. Almost all trials were originally related to HIV/AIDS research.

More recent work with the RESPOND Africa Group formerly at the Liverpool School of Tropical Medicine and now with the University College London Institute for Global Health has expanded into Diabetes (DM), Hypertension (HTN) and models of integrating care in Africa (https://inteafrica.org) for the three main chronic conditions -- HIV/DM/HTN.

See also https://www.ucl.ac.uk/global-health/respond-africa

The implementations we have developed are mostly eSource systems rather than the traditional EDCs.

The clinicedc for each trial consists of a subset of trial-specific modules that reference this module.

(python 3.12, Django 4.2, MySQL 8+, see setup.cfg)

How we describe the EDC in our protocol documents

Here is a simple example of a data management section for a study protocol document: data_management_section

Projects that use clinicedc

Recent examples of clinicedc applications using this codebase:

INTECOMM

Controlling chronic diseases in Africa: Development and evaluation of an integrated community-based management model for HIV, Diabetes and Hypertension in Tanzania and Uganda

https://github.com/intecomm-trial/intecomm-edc (2022- )

EFFECT

Fluconazole plus flucytosine vs. fluconazole alone for cryptococcal antigen-positive patients identified through screening:

A phase III randomised controlled trial

https://github.com/effect-trial/effect-edc (2021- )

http://www.isrctn.com/ISRCTN30579828

META Trial (Phase III)

A randomised placebo-controlled double-blind phase III trial to determine the effects of metformin versus placebo on the incidence of diabetes in HIV-infected persons with pre-diabetes in Tanzania.

https://github.com/meta-trial/meta-edc (2021- )

(The same codebase is used for META Phase 2 and META Phase 3)

http://www.isrctn.com/ISRCTN77382043

Mapitio

Retrospective HIV/Diabetes/Hypertension Cohort (Tanzania)

https://github.com/mapitio/mapitio-edc (2020-2022)

MOCCA

Integrated care for HIV and non-communicable diseases in Africa: a pilot study to inform a large-scale trial (MOCCA and MOCCA Extension Study)

https://github.com/mocca-trail/mocca-edc (2020-2022)

http://www.isrctn.com/ISRCTN71437522

INTE Africa Trial

Evaluating the integration of health services for chronic diseases in Africa

(32 sites in Uganda and Tanzania)

https://github.com/inte-africa-trial/inte-edc (2020-2022)

https://inteafrica.org

http://www.isrctn.com/ISRCTN43896688

META Trial (Phase II)

A randomised placebo-controlled double-blind phase II trial to determine the effects of metformin versus placebo on the incidence of diabetes in HIV-infected persons with pre-diabetes in Tanzania.

(3 sites in Tanzania)

https://github.com/meta-trial/meta-edc (2019-2021)

http://www.isrctn.com/ISRCTN76157257

The Ambition Trial

High dose AMBISOME on a fluconazole backbone for cryptococcal meningitis induction therapy in sub-Saharan Africa

(7 sites in Botswana, Malawi, South Africa, Uganda, Zimbabwe)

https://github.com/ambition-trial/ambition-edc (2018-2021)

http://www.isrctn.com/ISRCTN72509687

Start with main repo ambition-edc

The Botswana Combination Prevention Project

(30 remote offline sites in Botswana)

https://github.com/botswana-combination-prevention-project (2013-2018)

https://clinicaltrials.gov/ct2/show/NCT01965470

https://www.ncbi.nlm.nih.gov/pubmed/?term=NCT01965470

https://aids.harvard.edu/tag/bcpp/

Start with main repo bcpp

Contacts

For further information go to https://github.com/erikvw.

edc-action-item
edc-adverse-event
edc-appconfig
edc-appointment
edc-auth
edc-consent
edc-constants
edc-crf
edc-dashboard
edc-data-manager
edc-device
edc-document-status
edc-egfr
edc-export
edc-facility
edc-fieldsets
edc-form-describer
edc-form-label
edc-form-runners
edc-form-validators
edc-identifier
edc-lab
edc-lab-dashboard
edc-lab-panel
edc-lab-results
edc-label
edc-list-data
edc-listboard
edc-locator
edc-ltfu
edc-metadata
edc-model
edc-model-admin
edc-model-fields
edc-model-form
edc-navbar
edc-next-appointment
edc-notification
edc-offstudy
edc-pdf-reports
edc-pdutils
edc-prn
edc-protocol
edc-protocol-incident
edc-qareports
edc-randomization
edc-refusal
edc-registration
edc-reportable
edc-review-dashboard
edc-screening
edc-search
edc-sites
edc-subject-dashboard
edc-test-utils
edc-timepoint
edc-transfer
edc-unblinding
edc-utils
edc-visit-schedule
edc-visit-tracking

Contrib

edc-adherence
edc-csf
edc-dx
edc-dx-review
edc-glucose
edc-he
edc-mnsi
edc-microbiology
edc-microscopy
edc-pharmacy
edc-pharmacy-dashboard
edc-qol
edc-rx
edc-vitals

Thanks to JetBrains for support with an opensource PyCharm IDE license.